Global pharmaceutical major Lupin Limited has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg.

The approved tablets are bioequivalent to Provigil, the reference listed drug (RLD) of Nuvo Pharmaceuticals (Ireland) DAC. 

Modafinil is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) and shift work disorder (SWD).

According to IQVIA data, the U.S. market for Modafinil Tablets, based on the Provigil reference product, recorded estimated annual sales of USD 70.7 million for the 12 months ended July 2026.